Label: COLD AND HOT MEDICATED LARGE- menthol patch
- NDC Code(s): 52000-033-41
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 13, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
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WARNINGS:
EXTERNAL USE ONLY
When using this product
USE ONLY AS DIRECTED. • do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.
STOP USE and ask a doctor if
• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present • skin irritation develops
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
FAST RELIEF OF MINOR ACHES AND PAINS
*Compare to the active ingredient in Icy Hot® Patch
Contains Menthol 5%
Pain relieving ointment on a breathable adhesive pad
EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours. The thin, flexible patch is comfortable to wear and is easy to remove.
*This product is NOT manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.
Distributed by:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
- Packaging
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INGREDIENTS AND APPEARANCE
COLD AND HOT MEDICATED LARGE
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 428.5 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALCOHOL (UNII: 3K9958V90M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TARTARIC ACID (UNII: W4888I119H) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-033-41 1 in 1 BOX 06/21/2017 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/21/2017 Labeler - Universal Distribution Center LLC (019180459) Registrant - Universal Distribution Center LLC (019180459) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(52000-033)